An excellent opportunity has arisen for an experienced Clinical Project Manager to join my client based in Paris, France.
Responsibilities:
- Design, implementation and coordination of clinical studies with the support of the Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing departments
- Planning the clinical development program
- Writing protocols, amendments and study reports
- Writing regulatory files
- Managing relationships with investigators and opinion leaders
- Implementation and monitoring of actions to meet recruitment deadlines and good clinical practices
Profile:
- Holder of additional training in methodology (CESAM, DIU, ...)
- Successful experience as a Clinical Project Manager in a pharmaceutical laboratory or CRO
- 6 to 8 years of experience clinical development (phase II and III)
- Experience in oncology or in auto-immune inflammatory pathologies would be a bonus
- International development experience essential
- Control of the regulatory environment for clinical trials
- Experience in writing study reports and FDA (IND, NDA) and EMA regulatory dossiers
- Fluent English imperative
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: BH-34151
Website: Achieva Group Limited
- Posted: 13th January 2023
- Expires: 10th February 2023